An enterostomy procedure, such as a colostomy or illeostomy, is often indicated for patients with colorectal disease or injury to the intestine in which the colon is removed or cannot safely pass solid wastes that would otherwise exit the body through the anus. In such a procedure, the physician must create a stoma, a surgically created opening through the fascia and muscular layers of the lower abdomen, to bypass the compromised bowel section. A bag is typically attached about the stomal opening to collect the patient's feces. In many patients, this a chronic condition so that the stoma and bag remain necessary for the remainder of the patient's life.
A frequent complication of creating an external stoma through the fascia is localized herniation of the bowel through the weakened area around the stomal opening. Without an intact muscle layer maintaining the intestines within the peritoneal cavity, a portion of the bowel may push through or against the weakened area as a visible bulge that is often painful and presents cosmetic issues. In some instances, a loop of the herniated bowel can become strangulated as it pushes out, a potentially serious condition. To correct a hernia problem, the physician is faced with the decision whether to repair the defect or dismantle the original stoma and relocate the opening to the other side of the abdomen, which of course requires a second surgical procedure with its associated morbidity and risks.
Surgical repair of parastomal hernias has been problematic. Resuturing the muscle and supporting tissues adjacent the stoma is a fairly straightforward solution, but long term success rates have been disappointing. Another option has been to implant a synthetic mesh patch around the stoma and suture it in place so that the mechanical load of the bowels against the abdominal wall is spread out over a larger area to reduce the risk of sutures pulling through the muscle, leading to failure of the repair. Mesh devices for parastomal hernia repair are available that include an open ‘keyhole’ channel extending inward from the lateral edge of mesh implant so that the device can be slipped around the existing stoma and sutured in place, typically beneath the underlying fascia. Preformed flaps about the implant opening extending inward toward the peritoneal cavity help secure the device about the stoma. Implantation of a synthetic mesh parastomal hernia repair device involves wrapping the mesh sheet around the opening and overlapping the edges adjacent the keyhole to ‘size’ the opening in the mesh to the diameter of the stoma. The mesh is then sutured or stapled to the abdominal wall.
It has been well documented that synthetic hernia repair devices can irritate or erode tissue adjacent the implant over time, which can lead to patient discomfort. Furthermore, synthetic mesh devices are most suitable for repairing an existing hernia and have been recognized as more problematic as a prophylaxis implant because concerns with field contamination and other complications. Given the high incidence of hernia formation around the stomal opening in patients having an ostomy procedure, it has been proposed that prophylactic reinforcement of the site around the surgically created stoma would be warranted as a means to reduce the incidence of post-surgery hernias.
What is needed is a hernia repair device configured to be safely and securely implanted about the region of the surgically created stoma and which can be configured according to patient anatomy to provide long term reinforcement of the stomal site, either prophylactically or to repair an existing hernia, without the complications and hernia recurrence rates associated with permanently-implanted synthetic mesh devices.